Abiomed’s heart pump, Impella RP, helps blood circulation for up to 14 days in patients who develop acute right heart failure following implantation, myocardial infarction, heart transplant or open-heart surgery.

The approval comes in the form of a humanitarian device exemption (HDE), given for devices to treat rare conditions, affecting less than 4,000 people in the United States per year, and ones which have no comparable products.

The agency, on Tuesday, asked the company to conduct two post-approval studies to evaluate Impella RP’s safety and benefit profile.